Recombinant DNA and Biosafety

All biological research conducted at Michigan Technological University and in particular, research involving recombinant DNA must be registered with the University’s Institutional Biosafety Committee (IBC).  Under NIH guidelines, the IBC is responsible for reviewing research involving recombinant DNA molecules conducted under the aegis of Michigan Technological University. Recombinant DNA molecules are defined as either (i) molecules that are constructed outside living cells by joining natural or synthetic DNA segments to DNA molecules that can replicate in a living cell, or (ii) DNA molecules that result from the replication of those described above.  

In the interest of biosafety the IBC is also responsible for the review of research applications that involve the use of biological organisms and/or materials requiring containment at biosafety levels greater than BSL-1.

I. REGULATIONS

The NIH Guidelines for Research Involving Recombinant DNA Molecules provide detailed procedures and practices for the containment and safe conduct of recombinant DNA research.  All institutions receiving NIH funding for recombinant DNA research must comply with these guidelines and all researchers working with recombinant DNA at the funded institution must also comply with the guidelines regardless of their individual source(s) of funding.  

The OSHA Bloodborne Pathogen Standard applies to laboratories working with human blood, blood products, body fluids, unfixed tissues/organs and cell lines.  The standard mandates universal precautions, exposure control, engineering and work practice controls, personal protective equipment, housekeeping and waste containment and disposal.  

Biosafety in Microbiological and Biomedical Laboratories (BMBL)
, published by the Centers of Disease Control and National Institutes of Health, outlines the principles of laboratory biosafety, providing information on topics such as risk assessment and laboratory biosafety level criteria.  The BMBL is accepted as the reference standard for safety in biological laboratories.  It is expected that all Principal Investigators conducting biological research at Michigan Technological University will comply with the standards and principles detailed in the BMBL.  

II. INSTITUTIONAL BIOSAFETY COMMITTEE (IBC)

To meet NIH requirements the IBC must have a minimum of five members. Two of those members will represent the community and its interests, with additional members bringing expertise in plant, animal and recombinant DNA research.  Collectively members of the committee shall have the expertise and capability to assess the safety of research involving recombinant DNA or biological organisms and materials and identify any potential risks to individual and public health and to the environment. IBC responsibilities include:

  1. Review of all research that is conducted at or sponsored by the University involving recombinant DNA subject to the NIH guidelines and research involving biological organisms and/or biological materials that require containment at biosafety levels greater than BSL-1 .  
  2. Notification of the Principal Investigator of the committee’s actions.
  3. Periodic review of recombinant DNA and biological research conducted at the University.
  4. Adopting emergency plans for accidental spills, personnel contamination, loss of containment and research related illnesses.
  5. Reporting any significant problems or violations of NIH guidelines and any significant research-related accident or illness to NIH/OBA

The committee meets on a quarterly basis to conduct business, recognizing that constraints related to the submission of grant applications and/or receipt of funding may require flexibility in meeting schedules.

III. REGISTRATION/REVIEW OF RESEARCH BY THE IBC

As a requirement of the NIH guidelines the IBC must review and approve all recombinant DNA research that is subject to the NIH guidelines.  All recombinant DNA research must be registered with the IBC, although it is anticipated that most research conducted at Michigan Technological University will fall into categories that are exempt from the NIH guidelines and formal IBC review.

Similarly, all laboratory research involving biological organisms and/or materials derived from biological sources must be registered with the IBC. Formal IBC review will be given to research with biological organisms or materials classified in risk group 2 or greater or requiring containment at biosafety levels greater than BSL-1.  Although most biological research conducted at Michigan Technological University is not specifically regulated by government agencies, the intent of the registration and review process is to ensure that all biological research conducted at the University is done in a manner that protects and maintains individual and community health and the health of the environment.   

The IBC review will include: ( i ) independent assessment of the risks associated with the research and verification of containment levels assigned by the PI. ( ii ) Assessment of facilities, equipment, procedures, practices, training and all other elements associated with the research.